The United States Food and Drug Administration (“FDA”) determines storage requirements for all blood and blood products. Among other things, the FDA requires that blood and/or blood products be stored within a specific temperature range. For example, after 8 hours, whole blood must be stored between 1 and 6 degrees Celsius. During transport, the whole blood must be kept between 1 and 10 degrees Celsius. Additionally, the FDA requirements also state that, after collection, blood products may only be outside of the specified temperature range for prescribed (brief) period of time. If the temperature of the blood or blood products remains outside of the target temperature range for longer than the allowed time, the blood and blood products must be disposed of. As one may expect, loss and disposal of any blood or blood product is wasteful and costly.
Furthermore, the FDA guidelines become more of an issue when one considers that blood and blood products are not always collected and immediately processed or placed within a fixed storage device or location. In most instances, the blood and/or blood products must be transported to a different location for permanent processing, storage, and/or use.
Currently, hospitals and blood donation organizations transport collected/stored blood and blood products in a consumer-type cooler (e.g., similar to those used to store beverages and food) with ice packs, bags of ice, or dry ice, for example. This method provides only limited transport time and cannot ensure that the stored blood and blood products remain within the target temperature range (e.g., the temperature may be above or below the target range). Additionally, this method cannot ensure that all of the blood and/or blood products within the cooler are at the same temperature (e.g., some of the blood product containers may be within the temperature range and others may not because of the uneven cooling provided by ice packs). Lastly, this method is unable to provide any information regarding how long the blood product has been stored and for how long the blood product was outside of the target temperature range. Therefore, in many instances, if the ice pack melts during transport and there is uncertainty as to whether or not the blood went over the target temperature, the blood and/or blood products must be disposed of. In other instances, the temperature of the blood or blood products is sampled at the processing center. If the blood or blood product falls within the specified range, the blood or blood product is cleared for processing even though the blood or blood unit may have been outside of the specified range at any point since collection.